TY - JOUR
T1 - Health-related quality-of-life results from the randomised phase II TAVAREC trial on temozolomide with or without bevacizumab in 1p/19q intact first-recurrence World Health Organization grade 2 and 3 glioma (European Organization for Research and Treatment of Cancer 26091)
AU - Reijneveld, Jaap C
AU - Machingura, Abigirl
AU - Coens, Corneel
AU - Taphoorn, Martin J B
AU - Taal, Walter
AU - Clement, Paul M
AU - Idbaih, Ahmed
AU - de Vos, Filip Y F
AU - Klein, Martin
AU - Wick, Wolfgang
AU - Mulholland, Paul J
AU - Lewis, Joanne
AU - Golfinopoulos, Vassilis
AU - Ghislain, Irina
AU - Bottomley, Andrew
AU - van den Bent, Martin J
N1 - Funding Information:
The trial was supported by an unrestricted educational grant and free supply of BEV by Roche. The drug manufacturer was not involved in trial design, data collection or analysis, interpretation of the data, nor in the writing of this report. JCR, CC, AB, MT and MvdB had full access to all of the data and the final responsibility to submit for publication.
Funding Information:
We thank all patients and their relatives for their willingness to participate in this clinical trial. We thank the European Organisation for Research and Treatment of Cancer (EORTC) Cancer Research Fund and EORTC staff for their invaluable assistance and support of this trial (Roxana Albu, Pieter Jespers, Jelena Laverty, Sylvie Ledroit, Sara Meloen, Jean-Paul Nzanzu, Christine Olungu, Nabila Sebti, Thibault Smets, Zineb Wadid and Lorraine Wheeler). We also thank all trial staff at the participating sites and the staff at Roche involved in this study.
Publisher Copyright:
© 2023 The Authors
PY - 2023/9
Y1 - 2023/9
N2 - BACKGROUND: In an international randomised controlled phase II study of temozolomide (TMZ) versus TMZ in combination with bevacizumab (BEV) in locally diagnosed non-1p/19q co-deleted World Health Organization grade 2 or 3 gliomas with a first and contrast-enhancing recurrence after initial radiotherapy, and overall survival at 12 months was not significantly different (61% in the TMZ arm and 55% in the TMZ + BEV arm).OBJECTIVES: Health-related quality of life (HRQoL) was a key secondary end-point in this trial, and the main objective of this study was to determine the impact of the addition of BEV to TMZ on HRQoL.METHODS: HRQoL was assessed using the European Organization for Research and Treatment of Cancer QLQ-C30 (version 3) and QLQ-BN20 at baseline, and then every 12 weeks until disease progression. The pre-selected primary HRQoL end-point was the QLQ-C30 global health scale, with self-perceived cognitive functioning and pain selected as secondary HRQoL issues. Analysis was undertaken using linear mixed modelling and complemented with sensitivity analyses using summary statistics. A difference was considered clinically relevant with ≥10 points difference on a 100-point scale.RESULTS: Baseline compliance was high at 94% and remained above 60% until 72 weeks, limiting the analysis to 60 weeks. Compliance was similar in both arms. We found no statistically significant or clinically significant differences between the primary HRQoL end-point in both treatment arms (p = 0.2642). The sensitivity analyses confirmed this finding. The overall test for post-baseline differences between the two treatment arms also showed no statistically or clinically significant differences regarding the selected secondary end-point scales.INTERPRETATION: The addition of BEV to TMZ in this patient group neither improves nor negatively impacts HRQoL.
AB - BACKGROUND: In an international randomised controlled phase II study of temozolomide (TMZ) versus TMZ in combination with bevacizumab (BEV) in locally diagnosed non-1p/19q co-deleted World Health Organization grade 2 or 3 gliomas with a first and contrast-enhancing recurrence after initial radiotherapy, and overall survival at 12 months was not significantly different (61% in the TMZ arm and 55% in the TMZ + BEV arm).OBJECTIVES: Health-related quality of life (HRQoL) was a key secondary end-point in this trial, and the main objective of this study was to determine the impact of the addition of BEV to TMZ on HRQoL.METHODS: HRQoL was assessed using the European Organization for Research and Treatment of Cancer QLQ-C30 (version 3) and QLQ-BN20 at baseline, and then every 12 weeks until disease progression. The pre-selected primary HRQoL end-point was the QLQ-C30 global health scale, with self-perceived cognitive functioning and pain selected as secondary HRQoL issues. Analysis was undertaken using linear mixed modelling and complemented with sensitivity analyses using summary statistics. A difference was considered clinically relevant with ≥10 points difference on a 100-point scale.RESULTS: Baseline compliance was high at 94% and remained above 60% until 72 weeks, limiting the analysis to 60 weeks. Compliance was similar in both arms. We found no statistically significant or clinically significant differences between the primary HRQoL end-point in both treatment arms (p = 0.2642). The sensitivity analyses confirmed this finding. The overall test for post-baseline differences between the two treatment arms also showed no statistically or clinically significant differences regarding the selected secondary end-point scales.INTERPRETATION: The addition of BEV to TMZ in this patient group neither improves nor negatively impacts HRQoL.
KW - Bevacizumab
KW - EORTC
KW - Glioma
KW - Health-related quality of life
KW - RCTs
KW - Temozolomide
UR - https://www.scopus.com/pages/publications/85165046463
U2 - 10.1016/j.ejca.2023.112946
DO - 10.1016/j.ejca.2023.112946
M3 - Article
C2 - 37453240
SN - 0959-8049
VL - 190
SP - 1
EP - 15
JO - European Journal of Cancer
JF - European Journal of Cancer
M1 - 112946
ER -